RecruitingPhase 2NCT05582538

Restoring Sensitivity To Immunotherapy In Advanced Triple Negative Breast Cancer Exploiting Ceralasertib Priming Followed By Combined Durvalumab/Nab-Paclitaxel

Restoring Sensitivity To Immunotherapy In Advanced Triple Negative Breast Cancer Exploiting Ceralasertib Priming Followed By Combined Durvalumab/Nab-Paclitaxel: The ATRiBRAVE Trial


Sponsor

IFOM ETS - The AIRC Institute of Molecular Oncology

Enrollment

37 participants

Start Date

Dec 15, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This study will evaluate the efficacy and safety of ceralasertib followed by durvalumab plus nab-paclitaxel in 37 patients with TNBC, whose tumor relapsed following treatment with curative intent for early disease, which must have included immunotherapy and chemotherapy as part of the radical locoregional therapy (either adjuvant, neoadjuvant or both).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (ATRiBRAVE) is testing a combination approach in people with advanced triple-negative breast cancer (TNBC) — a type that lacks hormone receptors and HER2 — that stopped responding to immunotherapy earlier. The treatment uses a drug called ceralasertib to sensitize the cancer, followed by immunotherapy (durvalumab) plus chemotherapy (nab-paclitaxel). **You may be eligible if...** - You are 18 or older - You have advanced triple-negative breast cancer - Your cancer was previously treated with immunotherapy and chemotherapy for early-stage disease, but has since progressed - You have not received chemotherapy for your advanced (metastatic) disease yet - A tumor tissue sample is available - You can swallow tablets **You may NOT be eligible if...** - You have already received chemotherapy for advanced/metastatic disease - You are unable to swallow oral medication - You have significant other health conditions that make the treatment unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGCeralasertib

240mg orally BD (dose level 0) on days -6 to 0 prior to day 1 cycle 1 and then on days 22 to 28 of cycle 1 and every subsequent cycle

DRUGDurvalumab

1500 mg i.v. day 1 (q28)

DRUGNab-paclitaxel

100mg/m2 i.v. day 1,8,15 (q28)


Locations(6)

Azienda Ospedaliero Universitaria Maggiore della Carità

Novara, Novara, Italy

ASST Papa Giovanni XXIII

Bergamo, Italy

Istituto Nazionale dei Tumori IRCCS

Milan, Italy

IRCCS Istituto Nazionale Tumori "Fondazione Giovanni Pascale"

Naples, Italy

Istituto Oncologico Veneto IRCCS

Padova, Italy

Azienda U.S.L. - IRCCS di Reggio Emilia

Reggio Emilia, Italy

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05582538


Related Trials